Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
aprepitant, Quantity: 40 mg
Southern Cross Pharma Pty Ltd
Capsule, hard
Excipient Ingredients: iron oxide yellow; hypromellose; poloxamer; sucrose; Gelatin; sodium lauryl sulfate; titanium dioxide; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
1
(S4) Prescription Only Medicine
Aprepitant in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:,? highly emetogenic cancer chemotherapy.,? moderately emetogenic cancer chemotherapy,Aprepitant is indicated for the prevention of postoperative nausea and vomiting.
Visual Identification: opaque hard gelatin capsules with a yellow cap and white body, printed with 40mg on the body; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-07-03
APREPITANT SCP/102018/CMI-00 1 APREPITANT SCP _contains the active ingredient aprepitant _ _ _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about APREPITANT SCP. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking APREPITANT SCP against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What APREPITANT SCP is used for CHEMOTHERAPY INDUCED NAUSEA AND VOMITING APREPITANT SCP, in combination with other medicines, is used to prevent nausea (feeling sick) and vomiting associated with cancer chemotherapy. POST-OPERATIVE NAUSEA AND VOMITING APREPITANT SCP is used to prevent nausea (feeling sick) and vomiting which can occur after surgery. APREPITANT SCP belongs to a group of medicines called neurokinin 1 (NK1) receptor antagonists. It works by blocking the actions of substances in your brain, called substance P neurokinins, that cause nausea and vomiting. APREPITANT SCP is available only with a doctor's prescription. Your doctor may have prescribed APREPITANT SCP for another reason. Ask your doctor if you have any questions about why APREPITANT SCP has been prescribed for you. The safety and effectiveness of APREPITANT SCP in children and teenagers under the age of 18 years have not been established. APREPITANT SCP is not addictive. Before you take APREPITANT SCP _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE APREPITANT SCP IF YOU HAVE AN ALLERGY TO APREPITANT SCP OR ANY OF THE INGREDIENTS LISTED AT THE END OF THE LEAFLET. DO NOT TAKE APREPITANT SCP IF YOU ARE TAKING: • cisapride, used to treat stomach reflux • pimozide, used to treat psychotic • conditions • terfenadine (Teldane*) and astemizole (Hismanal*), antihistamines used for allergic conditions, inclu Կարդացեք ամբողջական փաստաթուղթը
AUSTRALIAN PRODUCT INFORMATION APREPITANT SCP, (APREPITANT) CAPSULES _ _ 1. NAME OF THE MEDICINE Aprepitant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule of APREPITANT SCP for oral administration contains 40 mg, 80 mg, 125 mg or 165 mg of aprepitant. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM APREPITANT SCP is available in a 40mg, 80mg, 125mg and 165mg capsule. The APREPITANT SCP 40 mg capsules are opaque hard gelatin capsules with a yellow cap and white body, printed with “40mg” on the body. The APREPITANT SCP 80 mg capsules are opaque hard gelatin capsules with a white cap and white body, printed with “80mg” on the body. The APREPITANT SCP 125 mg capsules are opaque hard gelatin capsules with a pink cap and white body, printed with “125mg” on the body. The APREPITANT SCP 165 mg capsules are opaque hard gelatin capsules with a blue cap and white body, printed with “165mg” on the body. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS APREPITANT SCP, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: • highly emetogenic cancer chemotherapy. • moderately emetogenic cancer chemotherapy APREPITANT SCP is indicated for the prevention of postoperative nausea and vomiting. 4.2. DOSE AND METHOD OF ADMINISTRATION GENERAL INFORMATION APREPITANT SCP may be taken with or without food. It is recommended that APREPITANT SCP 165 mg be taken with or without a light (low fat) meal, as administration with a high fat meal results in a 47% increase in systemic exposure of aprepitant see Section 5.2 PHARMACOKINETICS PROPERTIES. No dosage adjustment is necessary based on age, gender or race. No dosage adjustment is necessary for patients with severe renal insufficiency (creatinine clearance <30 mL/min) or for patients with end stage renal disease undergoing haemodialysis. APREPITANT SCP – AUSTRALIAN PRODUCT INFORMATION 2 No dosage adjustm Կարդացեք ամբողջական փաստաթուղթը